MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 403128

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device is available for investigation.Teleflex has requested this information.Two photos were received for analysis.One shows device with package insert with lot number 74f1600148.The other shows an aqua pak bottle.No other issues were found.The lot number was reported as unknown.However, a device history record was reviewed of the lot 74f1600148 and no issues or discrepancies were found which could potentially relate to this complaint.Customer complaint cannot be confirmed based on the information received.The device sample is necessary to perform a proper investigation to confirm the alleged defect and determine the root cause.If the device becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the adaptor for the oxygen outlet is easily dislocated from the aquapak" which is causing leaking.Alleged defect reported as detected during use.There was no report of patient injury.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed and no issues were encountered.As an additional test, the sample was assembled with a sterile water concha mini bottle.During the assembly and testing, no issues or discrepancies were found that can lead to the condition reported by the customer.Based on the investigation performed, the reported complaint could not be confirmed.There were no functional issues found with the returned sample.

Event Description

Customer complaint alleges "the adaptor for the oxygen outlet is easily dislocated from the aquapak" which is causing leaking.Alleged defect reported as detected during use.There was no report of patient injury.

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7131037
• MDR Text Key: 95525456
• Report Number: 3004365956-2017-00424
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: BA
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 403128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1